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| ID | Type | Description | Link |
|---|---|---|---|
| dongying | Other Grant/Funding Number | Dongying leader pharmaceutical co.,LTD |
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This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four centers in chongqing. 180 IBS-D patients in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open treatment period (8 weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks), the main outcome measures are pain intensity (NRS score 11 point scale) and stool type ( Bristol type). And secondary endpoints included overall symptoms sensory scores, defecation frequency, abdominal distension, mucous stool and quality of life parameters (IBS-36 scale). After the end of the treatment period, the participants whose pain intensity and stool type are effective subjects into a randomized withdrawal period, analysis and comparison of the difference between treatment group and placebo group withdrawal rate and curative effect index score reduces.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starch capsule | Placebo Comparator | During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper. |
|
| N-acetyl-D-glucosamine | Experimental | During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl-D-glucosamine | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain Intensity | As measured by numerical rating scale | one and a half years |
| Stool Consistency | As measured by Bristol ' s scale | one and a half years |
| Measure | Description | Time Frame |
|---|---|---|
| General symptoms feel grading | As measure by patient reported outcome measures | one and a half years |
| defecation frequency | As measure by patient reported outcome measures |
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Inclusion Criteria:
At least a portion of the time abdominal pain or defecate increase when discomfort.
At least a portion of the time abdominal pain or the row of loose stools when discomfort.
At least a portion of the time abdominal pain or discomfort improved after defecation.
Symptoms for at least 6 months before diagnosis
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junkang Liu, Doctor | Contact | +86-023-68752191 | liujunkang@163.com | |
| Yanxia Liu, Master | Contact | +86-023-68752190 | liuyibin_04@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junkang Liu, Doctor | Third MMU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping hospital | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000117 | Acetylglucosamine |
| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
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| Drug |
|
| one and a half years |
| abdominal distension | As measure by patient reported outcome measures | one and a half years |
| mucous stool | As measure by patient reported outcome measures | one and a half years |
| life quality parameters | As measure by healthy survey, SF-36 | one and a half years |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |